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CompletedNCT03262922PRESSYUpdated Apr 4, 2022

Clinical and Paraclinical Characteristics of the Systemic Scleroderma Cohort According to the Criteria ACR 2013 and the History of Professional Exposure or of Agricultural Environment

An observational study in Systemic Scleroderma, sponsored by Rennes University Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-04.

Sponsored by Rennes University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
327
Ages
18 Years and older
Sex
All
01

Study summary

The aim of the study is to compare the exposure to environmental and professional toxics by patients with systemic scleroderma and by patients not achieved by this pathology.

Read the detailed description

This study is based on a questionnaire.

The data will be collected according a retrospective and prospective design :

  • at diagnostic of the disease
  • at the inclusion in the systemic scleroderma cohort
  • during the annual visit (in 2017-2018-2019-2020)
02

Conditions studied

  • Systemic Scleroderma

Keywords

  • systemic scleroderma
  • environmental and professional toxics
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with systemic scleroderma

Inclusion criteria

  • Patients with systemic scleroderma

Exclusion criteria

Exclusion Criteria:

-

04

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
327 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Questionnaire to evaluate the exposition of environmental and professional toxics

    clinical, personal and professional data

    Time frame: once a year up to 2020

06

Study locations

1 site
  • CHU de Rennes
    Rennes, France
07

Registry details

Key details

Study ID
NCT03262922
Lead sponsor
Rennes University Hospital
Responsible party
Sponsor
First posted
Aug 25, 2017
Start date
Jul 29, 2016
Primary completion
Dec 31, 2019
Completion
Feb 18, 2022
Last update
Apr 4, 2022

Study contacts

Patrick JEGO, Pr
principal investigator · Rennes University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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